a study of ly2405319 in participants with type 2 diabetes

Conditions: Diabetes Mellitus, Type 2

Summary: the main purpose of this study was to evaluate the safety and tolerability of ly2405319. it was given as a daily injection under the skin to participants with type 2 diabetes mellitus (t2dm) for 28 days. this study determined how long the drug stays in the body and how it affects blood sugar levels. after screening, the study lasted about 2 months for each participant. participants continued their prestudy regimen of diet and exercise alone or in combination with metformin.


Eligibility criteria:
inclusion criteria: * have a diagnosis of t2dm. * are on diet and exercise or diet, exercise, and metformin (stable dose of at least 1000 mg/day for at least 60 days) regimen. * have a glycosylated hemoglobin a1c (hba1c) value of 7.0% to 10.0%, inclusive, or are on metformin and an additional oral antidiabetic medication (oam) with an hba1c value of 6.5% to 9.5%, inclusive. * participants on another oam in addition to metformin therapy may be randomized if removed from treatment of the other oam ≥14 days prior to study drug administration and fasting blood glucose is ≥145 mg per deciliter (mg/dl) and ≤270 mg/dl. * are females not of child-bearing potential due to surgical sterilization or are postmenopausal. * have a body mass index (bmi) ≥25 and ≤40. * have clinical laboratory test results within normal reference range for the population. exclusion criteria: * use insulin, thiazolidinediones (tzds), dipeptidyl peptidase (dpp) iv inhibitors, or exenatide during the 3 months prior to screening. * have had more than 1 episode of severe hypoglycemia requiring assistance of another person to administer a resuscitative action within 6 months prior to entry into the study or are currently diagnosed with having hypoglycemia unawareness. * have had 2 or more emergency room visits or hospitalizations due to poor glucose control in the past 6 months. * have any abnormality of the electrocardiogram (ecg) that will, in the opinion of the investigator, impair the ability to measure the qt (a corrected qc \[qtc\] \[bazett's correction\] interval \>450 milliseconds \[msec\] for men and \>470 msec for women or a pr interval \>220 msec are specifically excluded) or have conduction abnormalities that may confound the qtc analysis. * have a personal or family history of long qt syndrome, family history of sudden death, personal history of unexplained syncope within the last year; or use prescription or over-the-counter medications known to prolong the qt or qtc interval. * have diastolic blood pressure (dbp) ≥95 millimeters of mercury (mm hg) and/or systolic blood pressure (sbp) ≥160 mm hg. * have an active or untreated malignancy or have been in remission from a clinically significant malignancy for \<5 years. * have a history of a transplanted organ. * evidence of a significant active, uncontrolled endocrine or autoimmune abnormality, as judged by the investigator, at screening. * have a history of human immunodeficiency virus (hiv). * have a known allergy to yeast or yeast proteins, history of anaphylaxis with bronchospasm, or atopic dermatitis with chronic urticaria. * have any other condition (including known drug or alcohol abuse or psychiatric disorder within the last 6 months) that may preclude the participant from following and completing the protocol. * have a significant history of or current cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine (including pancreatitis), hematological, or neurological disorders capable of significantly altering the absorption, metabolism, or elimination of drugs; of constituting a risk when taking the study medication; or of interfering with the interpretation of data. * are women who are breastfeeding. * have had a significant change in weight, defined as a gain or loss of at least 4 kilograms (kg) (9 pounds) in the 90 days prior to randomization. * have taken in the 30 days prior to randomization, a medication, herbal product, or nutritional supplement that affects adipose mass or distribution or energy balance. * are receiving chronic (\>2 weeks) systemic glucocorticoid therapy (excluding topical or inhaled preparations) or have received such therapy within 4 weeks immediately prior to second screening appointment. * have current or recent (within the past 3 months) use of gemfibrozil or fenofibrate, niacin, ezetimibe, or bile acid binding resins (for example, cholestyramines). stable statin therapy of ≥3 months will be allowed. * are currently taking central nervous system (cns) stimulant.